Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline Total sleep time at 6 months
研究概览
简要总结
Insomnia affects about 60% of the patients treated with radio-chemotherapy, a percentage twice higher compared to that observed in the general population. This sleep disorder increases cancer-related fatigue (CRF), the side effect most often reported by patients. Conversely, it is well accepted that adapted physical activity (APA) improves tolerance to treatment, decreases the risk of recurrence, increases survival, and reduces CRF. The present study aims to evaluate, in non-metastatic breast cancer patients, the composition and architecture of sleep by ambulatory polysomnography and to verify the effects of an APA rehabilitation program (3 times a week during 12 weeks), on the quality and quantity of sleep, daytime sleepiness. The biological markers: melatonin and body temperature will be studied to better understand the chronobiological mechanisms of the sleep-wake rhythm. Finally, the physiological responses to exercise, pain, CRF and finally quality of life will be studied at the beginning, at the end of the program and at a distance from it. Improved sleep-wake rhythm by a physical activity may reduce CRF, prevent recurrence and comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65
- •Patients with non-metastatic breast cancer undergoing chemotherapy
- •Patients with insomnia
- •Certificate of non-contraindication to the practice of physical activity
- •Women who have been postmenopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
- •Signature of informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
- •Affiliation to a French social security scheme or beneficiary of such a scheme.
排除标准
- •Patients treated with melatonin or taking hypnotics
- •Patients with metastases
- •Oxygen saturation at rest (SaO2) ≤ 92%
- •Patients without insomnia and / or sleep disorders
- •Autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis)
- •Symptomatic osteoarthritis, cardiovascular disease (angina pectoris or uncontrolled hypertension) or lung disease (chronic obstructive pulmonary disease)
- •Patients suffering from malnutrition (BMI <18 kg.m-2) or weight loss> 10% during the previous 3 months
- •Patients with psychiatric or cognitive disorders deemed unsuitable for physical activity
- •Pregnant or breastfeeding women
- •Legal incapacity or limited legal capacity
- •Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
- •Subject without health insurance
- •Subject being in the period of exclusion from another study or provided for by the "national file of volunteers".
研究组 & 干预措施
Physical activity intervention
Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months.
干预措施: Physical activity (Other)
Control
Arm B : "standard oncologic care".
结局指标
主要结局
Change from baseline Total sleep time at 6 months
时间窗: 6 months
Evaluated with polysomnography
次要结局
- Change from baseline Score of fatigue at 6 months(6 months)
- Change from baseline quality of sleep at 6 months(6 months)
- Score of pain(Baseline (T0) , 3 months (T3).)
- Inflammatory responses(Baseline (T0), 3 months (T3).)
- Level of physical activity(Baseline (T0), 3 months (T3), 6 months (T6).)
- Basic respiratory functional exploration(Baseline (T0), 3 months (T3).)
- Level of anxiety(Baseline (T0), 3 months (T3), 6 months (T6).)
- Change from baseline body composition at 3 months(3 months.)
- Concentration of Melatonin(Baseline (T0), 3 months (T3), 6 months (T6).)
- Body temperature(Baseline (T0), 3 months (T3), 6 months (T6).)